Jessop Fertility
Sheffield, United Kingdom
NCT Number: NCT05671562
The goal of this clinical trial is to test whether lycopene (an antioxidant found in cooked tomatoes) will improve the number of swimming sperm in the ejaculates of men with low total motile sperm count.
Participants will take either lycopene capsules or identical capsules containing no lycopene for 12 weeks. We will analyse the quality of their semen before and after taking the capsules, and compare the results.
Hypothesis: Supplementation with lycopene will improve testicular function (semen quality) in males with low total motile sperm count (TMSC).
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Notify Me18 year–50 year
Male
Interventional
Not applicable
Sheffield, United Kingdom
Impaired testicular function contributes to around 50% of heterosexual infertility and is often characterized by a low total motile sperm count. Evidence suggests that one cause of low total motile sperm count is oxidative stress within the ejaculate, where harmful oxygen species damage the sperm. Antioxidants to combat oxidative stress within the ejaculate have been proposed as a method of increasing the total motile sperm count. Lycopene is a powerful antioxidant found abundantly in cooked tomatoes and has been shown to improve testicular function in a healthy population. This double blinded randomised controlled trial aims to investigate whether lycopene can improve testicular output in participants with a low motile sperm count. Semen analysis will be carried out before and after the intervention. The intervention is a commercially available lycopene capsule or an identical placebo.
Hypothesis: Supplementation with lactolycopene will improve testicular function (semen quality) in males with low total motile sperm count (TMSC).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Capsule containing lycopene 7mg x 2 daily for 12 weeks
Capsule containing inactive substance 7mg x 2 daily for 12 weeks
Time frame: Change from Baseline total motile sperm count at 12 weeks
Number of swimming sperm in the total ejaculate
Time frame: Change from Baseline sperm motility at 12 weeks
% of swimming sperm
Time frame: Change from Baseline sperm concentration at 12 weeks
Number of sperm per ml of ejaculate
Time frame: Change from Baseline sperm morphology at 12 weeks
Appearance of sperm
Time frame: Change from Baseline sperm DNA fragmentation at 12 weeks
% of sperm with fragmented DNA
Time frame: Change from Baseline semen oxidative reductive potential at 12 weeks
To compare level of oxidants and antioxidants within the sample
Sheffield Teaching Hospitals NHS Foundation Trust
Other
A Randomised Placebo-controlled Trial to Investigate the Effect of Lactolycopene on Sperm Quality in Men With a Low Total Motile Sperm Count: a Pilot Study.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.